Bentham P, Gray R, Sellwood E, Hills R, Crome P, Raftery J
Lancet Neurol. 2008 Jan;7(1):41-9. doi: 10.1016/S1474-4422(07)70293-4.
Cardiovascular risk factors and a history of vascular disease can increase the risk of Alzheimer's disease (AD). AD is less common in aspirin users than non-users, and there are plausible biological mechanisms whereby aspirin might slow the progression of either vascular or Alzheimer-type pathology. We assessed the benefits of aspirin in patients with AD.
310 community-resident patients who had AD and who had no potential indication or definite contraindication for aspirin were randomly assigned to receive open-label aspirin (n=156; one 75-mg enteric-coated tablet per day, to continue indefinitely) or to avoid aspirin (n=154). Primary outcome measures were cognition (assessed with the mini-mental state examination [MMSE]) and functional ability (assessed with the Bristol activities of daily living scale [BADLS]). Secondary outcomes were time to formal domiciliary or institutional care, progress of disability, behavioural symptoms, caregiver wellbeing, and care time. Patients were assessed at 12-week intervals in the first year and once each year thereafter. Analysis of the primary outcome measures was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN96337233.
Patients had a median age of 75 years; 156 patients had mild AD, 154 had moderate AD, and 18 had concomitant vascular dementia. Over the 3 years after randomisation, in patients who took aspirin, mean MMSE score was 0.10 points higher (95% CI -0.37 to 0.57; p=0.7) and mean BADLS score was 0.62 points lower (-1.37 to 0.13; p=0.11) than in patients assigned to aspirin avoidance. There were no obvious differences between the groups in any other outcome measurements. 13 (8%) patients on aspirin and two (1%) patients in the control group had bleeds that led to admission to hospital (relative risk=4.4, 95% CI 1.5-12.8; p=0.007); three (2%) patients in the aspirin group had fatal cerebral bleeds.
Although aspirin is commonly used in dementia, in patients with typical AD 2 years of treatment with low-dose aspirin has no worthwhile benefit and increases the risk of serious bleeds.
心血管危险因素和血管疾病史会增加患阿尔茨海默病（AD）的风险。AD在阿司匹林使用者中比非使用者中更少见，并且存在合理的生物学机制，阿司匹林可能借此减缓血管或阿尔茨海默病类型病理的进展。我们评估了阿司匹林对AD患者的益处。
310名患有AD且无阿司匹林潜在适应证或明确禁忌证的社区居民患者被随机分配接受开放标签的阿司匹林治疗（n = 156；每日1片75毫克肠溶包衣片，无限期持续服用）或避免使用阿司匹林（n = 154）。主要结局指标为认知功能（用简易精神状态检查表[MMSE]评估）和功能能力（用布里斯托尔日常生活活动量表[BADLS]评估）。次要结局为接受正式家庭护理或机构护理的时间、残疾进展、行为症状、照料者健康状况及护理时间。在第一年，患者每隔12周接受评估，此后每年评估一次。主要结局指标的分析采用意向性分析。本研究已注册为国际标准随机对照试验，编号为ISRCTN96337233。
患者的中位年龄为75岁；156例患者患有轻度AD，154例患有中度AD，18例伴有血管性痴呆。在随机分组后的3年里，服用阿司匹林的患者，其平均MMSE评分比被分配避免使用阿司匹林的患者高0.10分（95%CI -0.37至0.57；p = 0.7），平均BADLS评分低0.62分（-1.37至0.13；p = 0.11）。在任何其他结局测量中，两组之间均无明显差异。13例（8%）服用阿司匹林的患者和2例（1%）对照组患者因出血导致住院（相对风险 = 4.4，95%CI 1.5 - 12.8；p = 0.007）；阿司匹林组有3例（2%）患者发生致命性脑出血。
尽管阿司匹林常用于痴呆患者，但在典型AD患者中，低剂量阿司匹林治疗2年并无显著益处，且会增加严重出血的风险。
